Systems, Apparatus and Associated Methods for Needleless Delivery of Therapeutic Fluids

ABSTRACT

A needleless fluid delivery system for delivering therapeutic fluids to treatment sites within a patient. The fluid delivery system can include an automated injector source and a needleless access device. The access device can include a delivery scope and a treatment specific applicator. The automated injector source, delivery scope and applicator can be operably coupled with quick-connect style fittings so as to allow for quick replacement and maintenance of used or damaged components. The automated injector source can include a hands-free input mechanism allowing a medical professional to use both hands in manipulating the delivery scope and needleless applicator at the same time an injection is desired. The delivery scope and needleless applicator can comprise flexible or rigid lengths of tubing based on the accessibility of the treatment site. The needleless delivery system can include an imaging system for precisely position the applicator with respect to the treatment location.

PRIORITY CLAIM

The present application claims priority to U.S. Provisional ApplicationSer. No. 60/866,308 filed Nov. 17, 2006 and entitled, “SYSTEMS,APPARATUS, AND ASSOCIATED METHODS FOR NEEDLELESS DELIVERY OF THERAPEUTICFLUIDS”, which is herein incorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to the delivery of therapeuticfluids as part of a healthcare treatment. More specifically, the presentinvention relates to a needleless system for delivering a pressurizedfluid from an automated pressure source to an internal treatment sitewithin a patient undergoing medical treatment.

BACKGROUND OF THE INVENTION

A wide variety of medical treatments are at least partially performedthrough the delivery and introduction of therapeutic compositions to atreatment location. In home or outpatient settings, typical deliverymethods can comprise oral delivery, via liquid or solid forms, as wellas a variety of inhalant style devices. In clinical or hospitalsettings, therapeutic fluids are commonly injected using needle basedsystems. In some instances, the therapeutic fluid is delivered directlyinto a treatment location with a shot based injection while in otherinstances, a needle and drip line can be used to intravenously introducethe therapeutic to the vascular system whereby the therapeutic fluid iscarried and dispersed throughout the body. While needle based systemsare the unquestionably preferred delivery mechanism for certaintreatment methods, there remain a variety of treatment applicationswherein treatment sites within the body can be accessed without thecutting or piercing access provided by a needle. As such, it would beadvantageous to have a system capable of precisely delivering atherapeutic fluid to treatment sites within the body absent the cuttingand/or piercing access associated with needles.

SUMMARY OF THE INVENTION

The present invention comprises a fluid delivery system and relatedmethods for delivering therapeutic fluids to treatment sites within apatient. The fluid delivery system can comprise an automated injectorsource and a needleless access device. In some embodiments, the accessdevice can comprise a delivery scope and a treatment specificapplicator. In some embodiments, the automated injector source, deliveryscope and applicator can be operably coupled with quick-connect stylefittings so as to allow for quick replacement and maintenance of used ordamaged components. In some embodiments, the automated injector sourcecan comprise an input mechanism such as, for example, a foot pedalallowing a medical professional to provide a hands free input to theautomated injector source when an injection of therapeutic fluid isdesired. The delivery scope can comprise a length of flexible tubeproviding the medical professional an ability to easily maneuver theapplicator. In some embodiments, the applicator can comprise a rigid,steerable applicator capable of being individually maneuvered directlyto a treatment delivery site without the assistance of the deliveryscope while in still other embodiments, the applicator can comprise aflexible tube that is passively steered by the delivery scope or inconjunction with another introduction device such as, for example, acatheter. In yet another embodiment, the fluid delivery system cancomprise an imaging system allowing the medical professional toprecisely position the applicator with respect to a desired treatmentlocation.

In one aspect of the present disclosure, a needleless fluid deliverysystem can be used to deliver therapeutic fluids to treatment locationswithin a patient's body. The needleless fluid delivery system cancomprise an automated injector source and an access device. In someembodiments, the access device can comprise a delivery scope and aneedleless applicator. In some presently preferred embodiments, thevarious components of the needleless fluid delivery system can beoperably, fluidly connected using quick-connect fittings allowing forquick replacement and maintenance of used or damaged components as wellas providing flexibility to the needleless fluid delivery system byallowing the use of treatment specific components such as, for example,applicators that are specific to a particular type of body access ortreatment location. In one representative embodiment, the automatedinjector source can comprise a hand-free input mechanism such as, forexample, a foot pedal so as to provide a medical professional theopportunity to use both hands in properly manipulating the deliveryscope and needleless applicator. Depending upon treatment location andthe particular body access, the needleless applicator can beindividually steerable to a treatment delivery site or the needlelessapplicator can be passively steered using the delivery scope orintroduced with a separate introduction device such as a catheter. Inyet another embodiment, the fluid delivery system can either include orbe used in conjunction with an imaging system allowing the medicalprofessional to precisely position the needleless applicator withrespect, which may be especially advantageous when the automatedinjector source includes the hands-free input mechanism.

In another aspect of the present disclosure, a variety of applicatorscan be used in conjunction with a needleless fluid delivery system todeliver a therapeutic fluid to a treatment location within a patient'sbody. In one representative embodiment, a plurality of therapy-specificapplicators can each comprise a common attachment coupling so as to beselectively, individually attachable to an automated injector sourcecapable of operable interconnection with the attachment coupling. Insome embodiments, the variety of applicators can be individuallytailored to have desirable characteristics including, for example,flexibility or rigidity, steerable or non-steerable as well as a varietyof treatment interfaces. Applicators can be tailored for specifictreatment locations including, for example, a rectal treatment location,a gastrointestinal treatment location, a nasal treatment location, abronchial treatment location or an esophageal treatment location. Theapplicator can be attachable to a delivery scope and can be configuredeither for placement over the delivery scope or within the deliveryscope. Each applicator can comprise one or more applicator lumens forperforming treatment at the treatment location. In some embodiments, arepresentative applicator can have an injection lumen such as, forexample, an end-fire injection lumen for an end delivery of thetherapeutic fluid or the applicator can have a side-fire injection lumenfor a side delivery of the therapeutic fluid to the treatment location.In some embodiments, the applicator can further comprise a vacuum lumento position and retain issue with respect to the injection lumen.

In another aspect, the present disclosure is directed to a method fordelivering a therapeutic fluid to a treatment location within the bodyusing a pressurized fluid source so as to avoid the use of a needle inaccessing the treatment location. One representative method fordelivering the therapeutic fluid can first comprise accessing thetreatment location with an access device that includes a treatmentspecific applicator. In some embodiments, accessing the treatmentlocation can include imaging the treatment location with a medicalimaging system so as to verify the position of the treatment specificapplicator with respect to the treatment location. Depending upon thetreatment location, the treatment specific applicator can be rigid orflexible, individually steerable or carriable with an introducer,straight, curved or otherwise shaped. Presently contemplated treatmentscan include rectal and/or gastro intestinal, nasal, bronchial andesophageal treatments. At the treatment location, tissue to be treatedcan be captured and retained utilizing a vacuum introduced through thetreatment specific applicator. After the treatment location has beenaccessed and the tissue positioned using the treatment specificapplicator, the therapeutic fluid can be delivered to the treatment siteunder the direction of a high pressure injector. As the therapeuticfluid reaches the treatment site, the therapeutic fluid can be appliedto the treatment location through an injector lumen in the treatmentspecific applicator.

The above summary of the various representative embodiments of theinvention is not intended to describe each illustrated embodiment orevery implementation of the invention. Rather, the embodiments arechosen and described so that others skilled in the art may appreciateand understand the principles and practices of the invention. Thefigures in the detailed description that follows more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments of the inventionin connection with the accompanying drawings, in which:

FIG. 1 is a perspective view of an embodiment of a needleless fluiddelivery system for delivering a therapeutic fluid to a treatmentlocation according to the present disclosure.

FIG. 2 is side view of an embodiment of a needleless fluid deliverysystem for delivering a therapeutic fluid to a treatment locationaccording to the present disclosure.

FIG. 3 is a perspective view of an embodiment of an access device fordelivering a therapeutic fluid to a treatment location according to thepresent disclosure.

FIG. 4A is a perspective, end view of the access device of FIG. 3 in anover-scope configuration.

FIG. 4B is a perspective, end view of the access device of FIG. 3 in athrough-scope configuration.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit the invention to theparticular embodiments described. On the contrary, the intention is tocover all modifications, equivalents, and alternatives.

DETAILED DESCRIPTION OF THE DRAWINGS

In the following detailed description of the present invention, numerousspecific details are set forth in order to provide a thoroughunderstanding of the present invention. However, it will be obvious toone skilled in the art that the present invention may be practicedwithout these specific details. In other instances, well-known methods,procedures, and components have not been described in detail so as tonot unnecessarily obscure aspects of the present invention.

A needleless fluid delivery system 100 is illustrated generally inFIG. 1. Needleless fluid delivery system 100 can comprise an automatedinjector 102 and an applicator 104. Automated injector 102 can include auser interface 106, a controller 107 and a connector member 108. Userinterface 106 can comprise an input means for selectively delivering apressurized fluid through the connector member 108. Representative inputmeans can include switches and/or buttons. In one presently preferredembodiment, user interface 106 comprise a touch-screen capable ofreceiving touch commands as well as displaying system informationincluding a mode of operation as well as operating parameters.Controller 107 generally comprises a microprocessor or similar controlinstrument capable of communicating with user interface 106 and caninclude suitable memory for storing operational criteria.

As seen in FIG. 1, applicator 104 generally includes a scope portion 110and a delivery portion 112. Generally, a delivery lumen is continuouslydefined from a supply end 114 on the scope portion 110 to a delivery end116 on the delivery portion 112. Supply end 114 is generally configuredto fluid attached to the connector member 108. Delivery portion 112 cancomprise a variety of configurations depending upon a specifiedtreatment location in a patient's body such as, for example, a rectaltreatment location, a gastrointestinal treatment location, a nasaltreatment location, a bronchial treatment location or an esophagealtreatment location. In some embodiments, the delivery portion 112 can berigid or flexible, straight or curved, long or short, and the like.Representative embodiments of applicator 104 include a male urethraapplicator 104 a, a prostate applicator 104 b, a bladder applicator 104c, a female bladder/urethra applicator 104 d or a ureter/kidneyapplicator 104 e.

In some presently contemplated embodiments, applicator 104 and connectormember 108 or controller 107 can include a mechanical or electricalcommunication means for automatically communicating the applicator typeto the controller 107. In some embodiments, applicator 104 can comprisea microchip or a RFID tag 118 communicating with a receiving element 120on controller 107. When applicator 104 is attached to connector member108, RFID tag 118 can communicate and applicator type to the automatedinjector receiving element 120. Once the applicator type has beencommunicated to the receiving element 120, the controller 107 canpreconfigure the automated injector 102 for standard operatingconditions associated with the injector type. For example, attachment ofprostate applicator 104 b to connector member 108 instructs thecontroller 107 to prepare the automated injector 102 to prepare forstandard operating conditions relative to a prostate treatmentprocedure.

Another representative embodiment of a needleless fluid delivery system200 is illustrated generally in FIG. 2. Needleless fluid delivery system200 can comprise an automated injector 202 and a treatment access device204. Automated injector 202 can include a hands-free input device 206, afluid reservoir 208 and an injector coupling member 210. In onepresently preferred embodiment, the hands-free input device 206 cancomprise a foot pedal for initiating a pressurized injection of atherapeutic fluid through the treatment access device 204. Fluidreservoir 208 can comprise a manual injector 211 for supplying thetreatment fluid or to supplement the treatment fluid with additionalfluid. Injector coupling member 210 preferably comprises a quick-connectstyle fitting and preferably comprises a swivel or rotating design foraccommodating flexibility in the treatment access device 204.

Treatment access device 204 generally comprises an extension tube 212and an applicator 214. Generally, a fluid delivery lumen is operably,continually defined from an access device coupling member 216 to adelivery end 218 of the treatment access device 204. Applicator 214generally comprises a grasping portion 220 and a delivery portion 222.Extension tube 212 can preferably comprise a flexible extension tube 224allowing a medical professional to manipulate the grasping portion 220such that the delivery portion 222, and more specifically, an applicatorhead 226 to the desired treatment location within the body. Dependingupon the treatment location, applicator 214 can also includeconfigurations such as, for example, male urethra applicator 104 a,prostate applicator 104 b, bladder applicator 104 c, femalebladder/urethra applicator 104 d or ureter/kidney applicator 104 e.

A representative embodiment of an access device 300 is illustrated inFIG. 3. Access device 300 can comprise a flexible scope 302 operablycoupled to an applicator 304. Flexible scope 302 can include a supplyconnector 306 on a supply end 308 while applicator 304 includes anapplicator head 310 proximate a delivery end 312. Supply connector 306preferably comprises a quick-connect style fitting and can be configuredfor attachment to an automated injector such as, for example, automatedinjector 102 and/or automated injector 202. Applicator 304 generallycomprises a grasping portion 314 and a delivery portion 316. Deliveryportion 316 can comprise a flexible tube that is either individuallysteerable or passively steerable in conjunction with the flexible scope302. Delivery portion 316 can comprise any of a variety of applicatorstyles dependent upon the treatment location and can includeconfigurations such as, for example, male urethra applicator 104 a,prostate applicator 104 b, bladder applicator 104 c, femalebladder/urethra applicator 104 d or ureter/kidney applicator 104 e.

As illustrated in FIGS. 4A and 4B, applicator head 310 can comprise avariety of configurations depending upon convenience and efficacy inadministering a therapeutic fluid at the treatment location. Withreference to FIG. 4A, an over-scope applicator 400 can include a clearapplicator head 402 that operably slides over a flexible scope 404.Flexible scope 404 can include a scope vacuum lumen 406 a and a scopedelivery lumen 406 b. The flexible scope 404 can be advanced through theclear applicator head 402 until the scope vacuum lumen 406 a is fluidlyconnected to a head vacuum lumen 408 a and the scope delivery lumen 406b is fluidly connected to the head delivery lumen 408 b. Applicator head402 can include an alignment member 410 for assuring proper alignmentand engagement of the applicator head 402 and the flexible scope 404.When applicator head 402 and flexible scope 404 are operably connected,an automated injector can initiate a vacuum within the scope vacuumlumen 406 a and head vacuum lumen 408 a such that tissue at thetreatment location is drawn against a treatment end 412 of theapplicator head 402. With the tissue in direct contact with thetreatment end 412, an end-fire delivery of therapeutic fluid can bedelivered from the automated injector, through the scope delivery lumen406 b, out the head delivery lumen 408 b and onto/into the tissue.

Referring to FIG. 4B, a through-scope applicator 500 can include anapplicator head 502 that operably slides through a flexible scope 504.The applicator head 502 can include an applicator vacuum lumen 506 a andan applicator delivery lumen 506 b. The applicator head 502 isphysically configured such that the applicator vacuum lumen 506 a andthe applicator delivery lumen 506 b are properly positioned within aworking channel 508 on the flexible scope 504. When applicator head 502is positioned proximate the working channel 508, an automated injectorcan initiate a vacuum within the applicator vacuum lumen 506 a such thattissue at the treatment location is drawn into the working channel 508.With the tissue presented within the working channel 508, a side firedelivery of therapeutic fluid can be delivered from the automatedinjector, through the applicator delivery lumen 506 b, and onto/into thetissue.

With respect to the various needle free therapeutic fluid deliverysystems, access devices and applicators described herein, it will beunderstood that a medical professional preferably utilizes the systems,devices, methods and applicators as described along with a medicalimaging system such as, for example, computer axial tomography (CAT),magnetic resonance imaging (MRI), or in the case of treatment of aprostate gland, the preferred imaging means is transrectal ultrasound(TRUS). Through the use of a medical imaging system, a medicalprofessional can verify that the applicator, and more specifically, theapplicator head is properly inserted and positioned with respect to thedesired treatment location.

Once the applicator head is positioned with respect to the treatmentlocation, the medical professional can initiate a vacuum using eitherover-scope applicator 400 or through-scope applicator 500 to positionthe tissue proximate the appropriate delivery lumen. After verifyingthat the treatment location has been positioned with respect to thedelivery lumen with the medical imaging system, a user can initiatedelivery of a therapeutic fluid from the automated injector. In onepresently preferred embodiment, the medical professional can use bothhands to properly position the applicator and initiate delivery of thetherapeutic fluid with the hands-free input device 206.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit the invention to theparticular embodiments described. On the contrary, the intention is tocover all modifications, equivalents, and alternatives.

1. A needless fluid delivery system comprising: an automated injectorsource including a user interface and a connector member; and anapplicator including a scope portion and a delivery portion, the scopeportion adapted to attach to the connector member such that apressurized fluid from the automated injector source can be delivered toa treatment site through a delivery lumen defined within the applicator.2. The needleless fluid delivery system of claim 1, wherein the userinterface included an input means selected from the group consisting of:a foot pedal and a touch screen.
 3. The needleless fluid delivery systemof claim 1, wherein the applicator is selected from the group consistingof: a male urethra applicator, a prostate applicator, a bladderapplicator, a female bladder/urethra applicator and a ureter/kidneyapplicator.
 4. The needleless fluid delivery system of claim 1, whereinthe applicator includes a communication member for communicating anapplicator configuration to the automated injector source such that theautomated injector source preconfigures itself for standard operatingconditions consistent with the applicator configuration.
 5. The needlessfluid delivery system of claim 4, wherein the communication member isselected from the group consisting of: a microchip and a RFID tag. 6.The needleless fluid delivery system of claim 1, wherein the scopeportion includes a flexible scope and a supply connector adapted tooperably attach to the connector member.
 7. The needleless fluiddelivery system of claim 6, wherein the delivery portion includes aflexible tube that is steerable by the flexible scope.
 8. The needlelessfluid delivery system of claim 7, wherein the flexible tube includes atube vacuum lumen and a tube delivery lumen and an applicator head isslidably positioned over the flexible tube such that an applicatorvacuum lumen is operably connected to the tube vacuum lumen and anapplicator delivery lumen is operably connected to the tube deliverylumen wherein a vacuum source in the automated injector proximatestissue against a treatment end such that an injection fluid can bedelivered through the applicator delivery lumen at the treatment end. 9.The needleless fluid delivery system of claim 8, wherein an applicatorhead is slidably advanced through the flexible tube, the applicator headincluding an applicator vacuum lumen and an applicator delivery lumensuch that the applicator head can be advanced into a working channel inflexible tube such that a vacuum source in the automated injectorproximates tissue within the working channel wherein an injection fluidcan be delivered through the applicator delivery lumen at the workingchannel.
 10. A method for delivery a therapeutic fluid to a treatmentlocation comprising: providing a needleless delivery system including anautomated injector and an applicator; positioning a delivery end of theapplicator at a treatment location; and actuating an input device on theautomated injector to deliver a therapeutic fluid through the deliveryend.
 11. The method of claim 10, further comprising: communicating anapplicator configuration to the automated injector such that theautomated injector preconfigures itself for standard operatingconditions associated with the applicator configuration.
 12. The methodof claim 10, wherein actuating the input device comprises interfacingwith a touch screen on the automated injector.
 13. The method of claim10, wherein actuating the input device comprises stepping on a footpedal operably connected to the automated injector.
 14. The method ofclaim 10, wherein positioning the delivery end of the applicator at thetreatment location comprises: steering a flexible tube of the applicatorwith a flexible scope of the applicator; and attaching the flexiblescope to the automated injector.
 15. The method of claim 14, furthercomprising: sliding an applicator head over the delivery end; supplyinga vacuum through a vacuum lumen in the flexible tube to position tissueagainst the applicator head; and administering the therapeutic fluidinto the tissue through a delivery lumen in the applicator head.
 16. Themethod of claim 14, further comprising: advancing an applicator headthrough the flexible tube; supplying a vacuum through a vacuum lumen inthe applicator head to position tissue within a working channel on theflexible tube; and administering the therapeutic fluid into the tissuewithin the working channel through a delivery lumen in the applicatorhead.